For Patients

Lotensin (benazepril hydrochloride) is an angiotensin-converting enzyme inhibitor used to treat patients with hypertension. The drug is available in the generic form termed benazepril hydrochloride. Common side effects are dizziness, cough, nausea and drowsiness or lightheadedness; do not use when operating vehicles or machinery.

Lotensin is supplied as tablets containing strengths of 5, 10, 20, and 40 mg of benazepril hydrochloride for oral administration. The usual starting dose is 10 mg per day. Serious side effects include fainting, changes in urine output, blistering red skin rash, unusually tired, skin easily bruised or bleeds or the person may develop serious flu-like symptoms. Lotensin should not be used in pregnant females as it may damage the fetus. The drug has been found in breast milk so use in breast feeding women must be weighed against the possible harm to the infant. Lotensin is not recommended for children under 6 years old. However, doses of Lotensin between 0.1 and 0.6 mg/kg once daily have been studied, and doses greater than 0.1 mg/kg were shown to reduce blood pressure. Consequently, the recommended starting dose of Lotensin in children 6 years and older is 0.2 mg/kg once per day as monotherapy. Doses above 0.6 mg/kg have not been studied in children 6 years and older.

Our Lotensin Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

SIDE EFFECTS: Dizziness, lightheadedness, drowsiness, or headache may occur as your body adjusts to the medication. Dry cough may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: fainting, symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat), signs of infection (such as fever, chills, persistent sore throat), change in the amount of urine.

This drug may rarely cause serious (possibly fatal) liver problems. Tell your doctor right away if you notice any of the following rare but serious side effects: yellowing eyes/skin, dark urine, severe stomach/abdominal pain, persistent nausea/vomiting.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

SIDE EFFECTS

Lotensin has been evaluated for safety in over 6000
patients with hypertension; over 700 of these patients were treated for at
least one year. The overall incidence of reported adverse events was comparable
in Lotensin and placebo patients.

The reported side effects were generally mild and
transient, and there was no relation between side effects and age, duration of
therapy, or total dosage within the range of 2 to 80 mg. Discontinuation of
therapy because of a side effect was required in approximately 5% of U.S.
patients treated with Lotensin and in 3% of patients treated with placebo.

The most common reasons for discontinuation were headache
(0.6%) and cough (0.5%) (see PRECAUTIONS, Cough).

The side effects considered possibly or probably related
to study drug that occurred in U.S. placebo-controlled trials in more than 1%
of patients treated with Lotensin are shown below.

PATIENTS IN U.S. PLACEBO-CONTROLLED STUDIES

LOTENSIN
(N=964)

PLACEBO
(N=496)

N

%

N

%

Headache

60

6.2

21

4.2

Dizziness

35

3.6

12

2.4

Somnolence

15

1.6

2

0.4

Postural Dizziness

14

1.5

1

0.2

Other adverse experiences
reported in controlled clinical trials (in less than 1% of benazepril patients
or with less than 1% difference in incidence between benazepril or placebo
treatment), and rarer events seen in post-marketing experience, include the
following (in some, a causal relationship to drug use is uncertain):

Another potentially important
adverse experience, eosinophilic pneumonitis, has been attributed to other ACE
inhibitors.

Pediatric Patients: The adverse experience profile
for pediatric patients appears to be similar to that seen in adult patients.

Clinical Laboratory Test
Findings

Hemoglobin: Decreases in hemoglobin
(a low value and a decrease of 5 g/dL) were rare, occurring in only 1 of 2,014
patients receiving Lotensin alone and in 1 of 1,357 patients receiving Lotensin
plus a diuretic. No U.S. patients discontinued treatment because of decreases
in hemoglobin.